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Chewies

by Dentsply Sirona Orthodontics Inc. 11 variants

Ref AC150PGDS

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D746ALIGNERSEATER5E Basic UDI-DI D746AC150PGDS1UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD746AC150PGDS1 UDI-DI Date1 May 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Orthodontic aligner/retainer seater, single-use
Model / Ref / Catalog
AC150PGDS
Primary DI / UDI-DI
D746AC150PGDS1
Basic UDI-DI
++D746ALIGNERSEATER5E
FDA Product Code
ECS
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic aligner/retainer seater, single-use
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000002029
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Dentsply Sirona Orthodontics Inc.

See all devices from Dentsply Sirona Orthodontics Inc. →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No